Intervention Study to Prevent Obesity in Sedentary 8 Year Old Swedish Children

NCT ID: NCT01087411

Last Updated: 2021-02-24

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-10-31
• Study Completion Date: 2012-12-31

Brief Summary

The purpose of this study is to study whether a targeted intervention can increase physical activity in inactive 8-yr old children and how it affects secondary measures such as metabolic- and cardiovascular risk factors and markers, self-reported quality of life, BMI, body composition and aerobic work-capacity.

Detailed Description

Background Between 3 to 5 % of Swedish 10 yr olds are obese and an additional 20 % are over-weight. Being physically inactive in childhood increases the risk for becoming obese both in child- and adulthood and a correlation between BMI and arterial-sclerotic markers can be seen already in childhood. Physical activity (PA) in children improve their insulin sensitivity and reduce metabolic risk regardless of the proportion of fat mass. Published questionnaire data suggests that the level of PA has decreased in children between the years 1968 to 2001.

Study aims To study whether a targeted intervention can increase PA in sedentary 8-yr old children (2nd grade Swedish elementary school) and how it affects secondary measures such as; metabolic- and cardiovascular risk markers; self-reported quality of life, PA and motor skills; BMI; body composition; bone mineral density (BMD); PF. To identify factors of success that could be implemented in schools and pre-schools and in the commune and health-care parent support.

Subjects and methods With informed written consent of parents/caretakers we will screen at selected schools with questionnaires and accelerometers to identify sedentary children. The 30% most inactive children will be offered participation in the study. Cut off values for inactivity is obtained from a large reference-material based on 1800 measurements on 6 - 10 yr old children from the STOPP study. The intervention will be delivered through sessions aiming at developing healthy habits regarding PA and via supplementation with fish liver oil. The sessions will be performed by trained health workers (coaches) and carried out in the families' homes and later on via telephone. All families will meet with their coach during at least 6 times. The coaches will use the technique of Motivational Interviewing (MI). However, extra efforts, such as group work-out sessions and out-door activities, will be made. The individual work with these families is delicate and the intervention staff group will therefore have continuous education and guidance from a qualified MI tutor. All included children will be randomized to equally sized intervention or control group. All outcome measures will be assessed at 0 and 15 weeks (completion) of the intervention. The study is limited by the school semesters. Screening is therefore scheduled to the fall- and intervention program to spring semester.

Conditions

Cardiovascular Risk Factors; Metabolic Risk Factors; Sedentary Lifestyle; Overweight

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Motivational Interviewing and omega 3

This arm is the group that receives the intervention program and eats fish liver oil capsules. Represents 25 % of all participants.

Group Type: EXPERIMENTAL

Motivational Interviewing

Intervention Type: BEHAVIORAL

The method motivational interviewing according to Miller and Rollnik is used as an behavioral intervention to support the child and family in their own behavioral change towards a more physically active life style.

Physical activity

Intervention Type: BEHAVIORAL

Group sessions with different kinds of physical activity is arranged for the participants in the intervention program.

Supplementation with fish liver oli capsules

Intervention Type: DIETARY_SUPPLEMENT

This group will receive capsules containing omega-3 and omega-6 fatty acids and vitamine E. The dosage is six capsules daily containing omega-3 (558 mg of eico-pentaenoic-acid, EPA, and 174 mg of docosahexaenoic acid, DHA), omega-6 (60 mg of γ-linolenic acid, GLA) plus 9.6 mg vitamin E (in natural form, d-α-tocopherol), gelatin and glycerol. Participants will be instructed to eat three capsules each morning and evening.

Motivational interviewing and placebo

This arm is the group that receives the intervention program and eats placebo oil capsules. Represents 25 % of all participants.

Group Type: EXPERIMENTAL

Motivational Interviewing

Intervention Type: BEHAVIORAL

The method motivational interviewing according to Miller and Rollnik is used as an behavioral intervention to support the child and family in their own behavioral change towards a more physically active life style.

Physical activity

Intervention Type: BEHAVIORAL

Group sessions with different kinds of physical activity is arranged for the participants in the intervention program.

Placebo oil capsules

Intervention Type: DIETARY_SUPPLEMENT

This group will receive capsules containing rape seed oil. Participants will be instructed to lead their life in the same manner as before the intervention but eat three capsules each morning and evening.

Control and omega 3

This arm is the group that does not receives the intervention program and eats fish liver oil capsules. Represents 25 % of all participants.

Group Type: EXPERIMENTAL

Supplementation with fish liver oli capsules

Intervention Type: DIETARY_SUPPLEMENT

This group will receive capsules containing omega-3 and omega-6 fatty acids and vitamine E. The dosage is six capsules daily containing omega-3 (558 mg of eico-pentaenoic-acid, EPA, and 174 mg of docosahexaenoic acid, DHA), omega-6 (60 mg of γ-linolenic acid, GLA) plus 9.6 mg vitamin E (in natural form, d-α-tocopherol), gelatin and glycerol. Participants will be instructed to eat three capsules each morning and evening.

Control and placebo

This arm is the group that does not receives the intervention program and eats placebo oil capsules. Represents 25 % of all participants.

Group Type: PLACEBO_COMPARATOR

Placebo oil capsules

Intervention Type: DIETARY_SUPPLEMENT

This group will receive capsules containing rape seed oil. Participants will be instructed to lead their life in the same manner as before the intervention but eat three capsules each morning and evening.

Interventions

Motivational Interviewing

The method motivational interviewing according to Miller and Rollnik is used as an behavioral intervention to support the child and family in their own behavioral change towards a more physically active life style.

Intervention Type: BEHAVIORAL

Physical activity

Group sessions with different kinds of physical activity is arranged for the participants in the intervention program.

Intervention Type: BEHAVIORAL

Supplementation with fish liver oli capsules

This group will receive capsules containing omega-3 and omega-6 fatty acids and vitamine E. The dosage is six capsules daily containing omega-3 (558 mg of eico-pentaenoic-acid, EPA, and 174 mg of docosahexaenoic acid, DHA), omega-6 (60 mg of γ-linolenic acid, GLA) plus 9.6 mg vitamin E (in natural form, d-α-tocopherol), gelatin and glycerol. Participants will be instructed to eat three capsules each morning and evening.

Intervention Type: DIETARY_SUPPLEMENT

Placebo oil capsules

This group will receive capsules containing rape seed oil. Participants will be instructed to lead their life in the same manner as before the intervention but eat three capsules each morning and evening.

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

• Level of physical activity below the 30ieth percentile cut off point derived from a large reference population.

Exclusion Criteria

• Family not being able to participate in the program or take part in at least the physical activity assessment.
• Morbidities that affects the outcome parameters.

• Minimum Eligible Age: 7 Years
• Maximum Eligible Age: 9 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Karolinska Institutet

OTHER

Sponsor Role: lead

Responsible Party

Pernilla Danielsson

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Pernilla Danielsson Liljeqvist, MD

Role: PRINCIPAL_INVESTIGATOR

Karolinska Institutet

Locations

Karolinska Institutet, Dept. of Clinical Science, Intervention and Technology (CLINTEC), Division of Pediatrics.

Huddinge, Södermanland County, Sweden

Countries

Sweden

Other Identifiers

2008/1116-31/2

Identifier Type: OTHER

Identifier Source: secondary_id

STOPP-8

Identifier Type: -

Identifier Source: org_study_id